MAXFRAME 1100011-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982338570), received between Mar 13, 2023 and Aug 3, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT ARRIVED AT THE CLINIC WITH A BROKEN STRUT. STRUT #5 IS THE MEDIAL POSTERIOR AND IS THE SAME THAT BROKE PREVIOUSLY AND WAS REPORTED ON A PREVIOUS COMPLAINT. THE PATIENT STATED THAT THE STRUT HAD BROKEN EARLIER IN THE MORNING DURING PHYSICAL THERAPY. A NEW STRUT WAS PLACED AT STRUT #5 AND THE BROKEN STRUT WAS REMOVED AND IS AVAILABLE FOR RETURN. THIS PATIENT IS NOT SCHEDULED FOR ANYMORE STRUT CHANGES. REPROGRAMING THE HEAD UNIT WAS SUCCESSFUL AND THERE WAS NO NEGATIVE IMPACT TO THE PATIENT OR THE MAXFRAME PLAN. THIS REPORT IS FOR ONE (1) MAXFRAME AUTOSTRUT(TM) HEXAPOD STRUT - LONG. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17454011 ↗
• MalfunctionMar 13, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THAT AUTOSTRUT HEAD UNIT WAS MALFUNCTIONING. STRUT #5 MALFUNCTION. THERE WAS NO SURGICAL DELAY. THE SURGERY WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) XFRAME AUTOSTRUT(TM)HEXAPOD STRUT-LNG. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16528731 ↗